1. Field of the Invention
The present invention relates in general to a system and method in the field of prolapse treatment. More particularly, the present invention relates to an apparatus with multiple components and method for correcting tissue wall prolapse using the same. Specifically, a preferred embodiment of the present invention is a kit that has at least a pessary.
2. Discussion of the Related Art
As is known to those skilled in the art, the treatment of vaginal wall prolapse has been hampered by high failure rates. The main reasons for failure have been the inherent weakness of the tissue being re-approximated and the inability of the repair to withstand the forces applied by the abdominal cavity bearing down from above. In the last decade, one major advance in repair has been the addition of grafts to reinforce those repairs. While this phenomenon has been gaining wide spread acceptance, there lacks a consensus regarding how to affix the graft under the vaginal wall to best maintain durability and vaginal caliber. Note that vaginal caliber is important because of its impact on sexual function.
Unfortunately, with current procedures, the graft is at risk for being dislodged over time. For example, when the graft is sewn into place with standard sutures over the pelvic floor muscles, it is prone to cause pain from suture entrapment. Further, there is concern that sutures may be prone to pullout. This is especially true since the tissues the sutures are placed in are thin and inherently weak. Finally, the placement of the sutures is variable from surgeon to surgeon. This causes an impact on teaching proper graft placement.
All of the above issues may affect the success of the repair. Therefore, there is now greater interest in new ways of affixing and maintaining grafts. As a result, several recent procedure iterations have become available on the market in this regard.
With the introduction of new techniques, several improved devices, such as the Prolift™ device from Ethicon, Inc., have been made commercially available. Other commercial device kits are available in this field for prolapse repair that compete with Prolift™, for example, American Medical Systems' Apogee™ and Perigee™ system, Tyco's IVS Tunneller™ system, and Bard's Avaulta™ system. In general, these systems utilize medical mesh with wings at the corners so that the mesh may be drawn through the pelvic floor musculature and pelvic ligaments to secure the mesh.
A well-accepted access point to securing the wings of these systems has been through the obturatormembrane and ischiorectal fossa. Access is generally made viathese structures because the apex of the vagina is located deep with the pelvis. However, the problem with accessing the apex via these structures is that this anatomy is unfamiliar to surgeons. Further, safety remains a concern for surgeons because these systems require the passage of sharp needles long distances through these unfamiliar anatomic. Thus, extensive training and anatomy education is required to properly learn the technique. As a result, only a small number of surgeons have actually adopted these techniques.
The patents and publications of general interest here include: U.S. Pat. Nos. 6,936,052; 5,364,408; 5,458,609; 5,575,800; 5,662,664; 5,540,704; 6,470,890; U.S. Pat. Pub. Nos. 2005/0261545 and 2006/0052801; WO 2002/078568A1; WO 2003/028585A1; WO 2002/078552A1; and WO2004/045457A1. These patents and published applications disclose embodiments that were at least in part satisfactory for the purposes for which they were intended. The disclosures of all of these patents and applications in their entireties are hereby expressly incorporated by reference into the present application for purposes including, but not limited to, indicating the background of the present invention and illustrating the state of the art.
In general, the embodiments disclosed in the above-referenced patents and publications have the disadvantage that they are in general difficult or dangerous to use without extensive training. Also, they are only partially effective to treat prolapse. Other disadvantages include increased risk and ineffective results over time. For example, after sutures are made, the vagina is traditionally packed with gauze. This leads to significant discomfort after surgery. If the gauze is not removed within 24 hours, infection and other problems may develop.
Given the above, patients suffering prolapse either must wait long periods of time for treatment or forego the same altogether because of the risk involved and the necessary high-level of surgeon skill. It should be noted also that only a fraction of the hundreds of thousands of patients getting prolapse repair surgery are availed to the latest technology. This further leads to a procedure with a relatively high cost.
Therefore, what is needed is a relatively simple system and method. Further, what is also needed is a system and method that are easily repeatable and highly effective over time.